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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE DA VINCI MONOPOLAR SCISSOR (SI) SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE DA VINCI MONOPOLAR SCISSOR (SI) SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number REF# 420179 VER15
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2017
Event Type  malfunction  
Event Description
This reposable (si) intuitive instrument - monopolar scissor was returned to me with a note stating scissors not cutting. There was no indication of pt harm and the case was completed as planned. This instrument will be returned to intuitive for reimbursement.
 
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Brand NameDA VINCI MONOPOLAR SCISSOR (SI)
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE
sunnyvale CA 94086
MDR Report Key7420997
MDR Text Key105380846
Report NumberMW5076406
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF# 420179 VER15
Device Lot NumberN10170213 077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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